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== Approval ==
== Approval ==
The FDA approved baloxavir marboxil based on evidence of its benefits and side effects from two clinical trials in adult and pediatric patients with uncomplicated influenza (Trial 1, 1518T0821 and Trial 2, NCT02954354), involving 1119 patients.<ref name="FDA Snapshot">{{cite web | author = FDA Staff | date = July 23, 2019 | title=Drug Trial Snapshot: Xofluza | website=U.S. [[Food and Drug Administration]] (FDA) | url=http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-xofluza | access-date=7 January 2020}}</ref> Both trials included clincal sites and patients in Japan, with Trial 2 adding clinical locations in the United States.<ref name="FDA Snapshot" />
The U.S. [[Food and Drug Administration]] (FDA) approved baloxavir marboxil based on evidence of its benefits and side effects from two clinical trials in adult and pediatric patients with uncomplicated influenza (Trial 1, 1518T0821 and Trial 2, NCT02954354), involving 1119 patients.<ref name="FDA Snapshot">{{cite web | author = FDA Staff | date = July 23, 2019 | title=Drug Trial Snapshot: Xofluza | website=U.S. [[Food and Drug Administration]] (FDA) | url=http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-xofluza | access-date=7 January 2020}}</ref> Both trials included clincal sites and patients in Japan, with Trial 2 adding clinical locations in the United States.<ref name="FDA Snapshot" />


Baloxavir marboxil was approved for sale in Japan in February 2018.<ref>{{cite press release|url=http://www.publicnow.com/view/7E9FBF87835EEBAC31508CC4E1F96D3D77D54C0A|title=Xofluza (Baloxavir Marboxil) Tablets 10mg/20mg Approved For The Treatment Of Influenza Types A And B In Japan|date=23 February 2018|via=www.publicnow.com|publisher=[[Shionogi|Shionogi & Co., Ltd.]]}}</ref> On October 24, 2018, the U.S. [[Food and Drug Administration]] (FDA) approved it for the treatment of acute uncomplicated influenza in people 12 years of age and older who have been symptomatic for no more than 48 hours.<ref name=FDA/> The FDA application of baloxavir marboxil was granted [[priority review]] in the United States, and approval of Xofluza was granted to [[Shionogi]] & Co., Ltd. in October 2019.<ref name=FDA/>{{verification needed}} Specifically, the FDA approved the use of Xofluza for people at high risk of developing influenza-related complications.<ref>{{cite press release | title=Genentech Announces FDA Approval of Xofluza (Baloxavir Marboxil) for People at High Risk of Developing Influenza-Related Complications | publisher=[[Genentech]] | via=Business Wire | date=17 October 2019 | url=https://www.businesswire.com/news/home/20191017005525/en | archive-url=https://web.archive.org/web/20191024061608/https://www.businesswire.com/news/home/20191017005525/en | archive-date=24 October 2019 | url-status=live | access-date=23 October 2019}}</ref>
Baloxavir marboxil was approved for sale in Japan in February 2018.<ref>{{cite press release|url=http://www.publicnow.com/view/7E9FBF87835EEBAC31508CC4E1F96D3D77D54C0A|title=Xofluza (Baloxavir Marboxil) Tablets 10mg/20mg Approved For The Treatment Of Influenza Types A And B In Japan|date=23 February 2018|via=www.publicnow.com|publisher=[[Shionogi|Shionogi & Co., Ltd.]]}}</ref> On October 24, 2018, the FDA approved it for the treatment of acute uncomplicated influenza in people 12 years of age and older who have been symptomatic for no more than 48 hours.<ref name=FDA/> The FDA application of baloxavir marboxil was granted [[priority review]] in the United States, and approval of Xofluza was granted to [[Shionogi]] & Co., Ltd. in October 2019.<ref name=FDA/>{{verification needed}} Specifically, the FDA approved the use of Xofluza for people at high risk of developing influenza-related complications.<ref>{{cite press release | title=Genentech Announces FDA Approval of Xofluza (Baloxavir Marboxil) for People at High Risk of Developing Influenza-Related Complications | publisher=[[Genentech]] | via=Business Wire | date=17 October 2019 | url=https://www.businesswire.com/news/home/20191017005525/en | archive-url=https://web.archive.org/web/20191024061608/https://www.businesswire.com/news/home/20191017005525/en | archive-date=24 October 2019 | url-status=live | access-date=23 October 2019}}</ref>


==References==
==References==

Revision as of 17:54, 8 January 2020

Baloxavir marboxil
Clinical data
Trade namesXofluza
Other namesS-033188/S-033447
AHFS/Drugs.comMonograph
MedlinePlusa618062
License data
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Identifiers
  • ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate
CAS Number
PubChem CID
UNII
KEGG
CompTox Dashboard (EPA)
Chemical and physical data
FormulaC27H23F2N3O7S
Molar mass571.55 g·mol−1
3D model (JSmol)
  • O=C(OCOC(C(C=C1)=O)=C(N1N([C@@H]2C3=CC=CC=C3SCC4=C(F)C(F)=CC=C24)[C@@]5([H])N6CCOC5)C6=O)OC
  • InChI=1S/C27H23F2N3O7S/c1-36-27(35)39-14-38-25-19(33)8-9-31-24(25)26(34)30-10-11-37-12-21(30)32(31)23-15-6-7-18(28)22(29)17(15)13-40-20-5-3-2-4-16(20)23/h2-9,21,23H,10-14H2,1H3/t21-,23+/m1/s1
  • Key:RZVPBGBYGMDSBG-GGAORHGYSA-N

Baloxavir marboxil, sold under the brand name Xofluza, is an antiviral medication for treatment of influenza A and influenza B. It is taken as a single dose by mouth. It may reduce the duration of flu symptoms by about a day.

It was approved for medical use in the United States in 2018. It was developed by Shionogi Co., a Japanese pharmaceutical company, and Roche AG.[1]

Medical use

As of September 2018, in the only report of a phase III randomized, controlled trial, baloxavir reduced the duration of influenza symptoms of otherwise healthy outpatients by about one day compared to a placebo treatment group, and comparable to what was seen for a oseltamivir treatment group. On the first day after baloxavir was started in its treatment group of patients, viral loads decreased more than in patients in either the oseltamivir or placebo groups; however, after five days, the effect on viral load of the single dose of baloxavir was indistinguishable from the effect observed following the complete, 5-day regimen of oseltamivir in its treatment group.[2][verification needed]

Resistance

In 2.2% of baloxavir recipients in the phase II trial and in about 10% of baloxavir recipients in the phase III trial, the infecting influenza strain had acquired resistance to the drug, due to variants of the polymerase protein displaying substitutions of isoleucine-38, specifically, the I38T, I38M, or I38F mutations.[2]

Side effects

Common side effects following the single dose administration of baloxavir were diarrhea and bronchitis.[3][better source needed] Adverse events were reported in 21% of people who received baloxavir, 25% of those receiving placebo, and 25% of oseltamivir.[2]

Mechanism of action

Baloxavir marboxil is an influenza therapeutic agent, specifically, an enzyme inhibitor targeting the influenza virus' cap-dependent endonuclease activity,[citation needed] one of the activities of the virus polymerase.[citation needed] In particular, it inhibits a process known as cap snatching,[citation needed] wherein virus derives short, capped primers from host cell RNA transcripts, using them for polymerase-catalyzed synthesis of its needed viral mRNAs.[4][non-primary source needed] A polymerase subunit binds to the host pre-mRNAs at their 5′-caps, then the polymerase's endonuclease activity catalyzes its cleavage "after 10–13 nucleotides".[4][non-primary source needed] As such, its mechanism is distinct from neuraminidase inhibitors such as oseltamivir and zanamivir.[citation needed]

Approval

The U.S. Food and Drug Administration (FDA) approved baloxavir marboxil based on evidence of its benefits and side effects from two clinical trials in adult and pediatric patients with uncomplicated influenza (Trial 1, 1518T0821 and Trial 2, NCT02954354), involving 1119 patients.[5] Both trials included clincal sites and patients in Japan, with Trial 2 adding clinical locations in the United States.[5]

Baloxavir marboxil was approved for sale in Japan in February 2018.[6] On October 24, 2018, the FDA approved it for the treatment of acute uncomplicated influenza in people 12 years of age and older who have been symptomatic for no more than 48 hours.[3] The FDA application of baloxavir marboxil was granted priority review in the United States, and approval of Xofluza was granted to Shionogi & Co., Ltd. in October 2019.[3][verification needed] Specifically, the FDA approved the use of Xofluza for people at high risk of developing influenza-related complications.[7]

References

  1. ^ Branswell, Helen (27 June 2018). "A flu drug — shown to reduce the duration of symptoms — could upend treatment in U.S." STAT.
  2. ^ a b c Hayden FG, Sugaya N, Hirotsu N, et al. (September 2018). "Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents". N. Engl. J. Med. 379 (10): 913–923. doi:10.1056/NEJMoa1716197. PMID 30184455.
  3. ^ a b c "FDA approves new drug to treat influenza". U.S. Food and Drug Administration (FDA) (Press release). 24 October 2018. Archived from the original on 24 October 2019. Retrieved 23 October 2019.
  4. ^ a b Dias A, Bouvier D, Crépin T, et al. (April 2009). "The cap-snatching endonuclease of influenza virus polymerase resides in the PA subunit". Nature. 458 (7240): 914–8. Bibcode:2009Natur.458..914D. doi:10.1038/nature07745. PMID 19194459.
  5. ^ a b FDA Staff (23 July 2019). "Drug Trial Snapshot: Xofluza". U.S. Food and Drug Administration (FDA). Retrieved 7 January 2020.
  6. ^ "Xofluza (Baloxavir Marboxil) Tablets 10mg/20mg Approved For The Treatment Of Influenza Types A And B In Japan" (Press release). Shionogi & Co., Ltd. 23 February 2018 – via www.publicnow.com.
  7. ^ "Genentech Announces FDA Approval of Xofluza (Baloxavir Marboxil) for People at High Risk of Developing Influenza-Related Complications" (Press release). Genentech. 17 October 2019. Archived from the original on 24 October 2019. Retrieved 23 October 2019 – via Business Wire.

Further reading

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